Anti-acne Efficacy of a Dermo-cosmetic Product Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer in Male and Female Subjects Presenting With Mild to Moderate Acne

NCT03832647 | Completed Phase 4

• 2 other identifiers: VCA 18-012018-A02481-54
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Study to evaluate the anti-acne efficacy of a dermo-cosmetic associated with the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment and to demonstrate that the dermo-cosmetic product can improve the local tolerance of the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment Multi centre, Randomised, Double blind, Controlled, Parallel (100 subjects per arm), Intra-subject \& inter subject comparisons

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• Evaluation of the anti-acne efficacy 1 (number of the retentional and inflammatory lesions)

  Change in the number of the retentional (open \& closed comedones) and inflammatory lesions (papulae, pustulae \& nodules (if applicable)) on face after a 12-week application period At Week 0 (before any application) and Week 12 (after a 12-week application period), a counting of the retentional (open \& closed comedones) and inflammatory lesions (papulae, pustulae \& nodules (if applicable)) will be performed by a Dermatologist. The counting will be broken down on several parts of the face (forehead, left and right cheeks and chin).

  Week 0 (baseline) and Week 12 (final time point)

Secondary Outcomes (22)

• Evaluation of the anti-acne efficacy 2 (number of the retentional and inflammatory lesions)

  Week 4 and Week 8 (intermediary times point)

• Change in the acne stage on face according to the Global Acne Evaluation scale after 4, 8 and 12-week application period

  Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

• Change in the residual marks visibility after 4, 8 and 12-week application period

  Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

• Change in the pores visibility after 4, 8 and 12-week application period

  Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

• Change in the skin shininess after 4, 8 and 12-week application period

  Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

Study Arms (2)

Salicylic acid & Epiduo 0.1%-2.5% Topical Gel

EXPERIMENTAL

Salicylic acid: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.

Combination Product: Epiduo; Drug: Salicylic Acid

Hydréane légère & Epiduo 0.1%-2.5% Topical Gel

PLACEBO COMPARATOR

Hydréane légère: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.

Combination Product: Epiduo; Other: Hydréane légère

Interventions

Epiduo COMBINATION_PRODUCT

100 per arm Adapalene/ Benzoyl Peroxide

Hydréane légère & Epiduo 0.1%-2.5% Topical Gel; Salicylic acid & Epiduo 0.1%-2.5% Topical Gel

Salicylic Acid DRUG

Salicylic Acid

Salicylic acid & Epiduo 0.1%-2.5% Topical Gel

Hydréane légère OTHER

moisturizer

Hydréane légère & Epiduo 0.1%-2.5% Topical Gel

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and/or female subjects aged 16 to 35 years
• Subjects presenting with mild to moderate acne (stage 2 or stage 3 with at least 12 inflammatory lesions on face according to the Global Acne Evaluation)
• Female subjects of child-bearing potential who:
• have no sexual intercourse and agreeing not to have any throughout the study or
• are surgically sterile (oophorectomy, hysterectomy or tubal ligation),
• Subjects and/or all legal representatives (for minor subjects) who have given written informed consent
• Subjects who are willing to comply with the study requirements
• Subjects with Social Security (health insurance) coverage (according to the French requirements)

You may not qualify if:

• Subjects with any systemic disorder or face dermatoses other than acne that would in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, or psoriasis)
• Subjects with a condition or receiving a medication and/or with a history of medical/surgical events which, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study
• Subjects with a history of skin cancer
• Female subjects who are pregnant (positive urine pregnancy test) or lactating or who are planning to become pregnant during the study
• Subjects with hypersensitivity to the active substances of Epiduo (Adapalene and/or benzoyl peroxide) or to one of its excipients
• Subjects who are sensitive to peroxides (oxygenated water)
• Subjects who have planned a major surgery during the study requiring hospitalization under general anesthesia and the use of systemic or topical drugs (e.g. antibiotics, anti-inflammatory) for more than 1 week
• Subjects who declare to be deprived of their freedom by administrative or legal decision or who are under guardianship
• Subjects who cannot be contacted by telephone in case of emergency
• Subjects belonging to the staff of the study centre

Sponsors & Collaborators

• Vichy Laboratoires: lead

Study Sites (1)

INTERTEK

Paris, 75013, France

Location

Related Publications (5)

• Bouloc A, Roo E, Imko-Walczuk B, Moga A, Chadoutaud B, Dreno B. A skincare combined with combination of adapalene and benzoyl peroxide provides a significant adjunctive efficacy and local tolerance benefit in adult women with mild acne. J Eur Acad Dermatol Venereol. 2017 Oct;31(10):1727-1731. doi: 10.1111/jdv.14379. Epub 2017 Jul 7.

  PMID: 28573779 RESULT

• Muguet Guenot L, Vourc'h Jourdain M, Saint-Jean M, Corvec S, Gaultier A, Khammari A, Le Moigne M, Boisrobert A, Paugam C, Dreno B. Confocal microscopy in adult women with acne. Int J Dermatol. 2018 Mar;57(3):278-283. doi: 10.1111/ijd.13910. Epub 2018 Jan 25.

  PMID: 29369333 RESULT

• Gollnick HP, Bettoli V, Lambert J, Araviiskaia E, Binic I, Dessinioti C, Galadari I, Ganceviciene R, Ilter N, Kaegi M, Kemeny L, Lopez-Estebaranz JL, Massa A, Oprica C, Sinclair W, Szepietowski JC, Dreno B. A consensus-based practical and daily guide for the treatment of acne patients. J Eur Acad Dermatol Venereol. 2016 Sep;30(9):1480-90. doi: 10.1111/jdv.13675. Epub 2016 May 14.

  PMID: 27177989 RESULT

• Nast A, Dreno B, Bettoli V, Bukvic Mokos Z, Degitz K, Dressler C, Finlay AY, Haedersdal M, Lambert J, Layton A, Lomholt HB, Lopez-Estebaranz JL, Ochsendorf F, Oprica C, Rosumeck S, Simonart T, Werner RN, Gollnick H. European evidence-based (S3) guideline for the treatment of acne - update 2016 - short version. J Eur Acad Dermatol Venereol. 2016 Aug;30(8):1261-8. doi: 10.1111/jdv.13776. No abstract available.

  PMID: 27514932 RESULT

• Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE, Leyden JJ, Reynolds RV, Silverberg NB, Stein Gold LF, Tollefson MM, Weiss JS, Dolan NC, Sagan AA, Stern M, Boyer KM, Bhushan R. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17.

  PMID: 26897386 RESULT

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene, Benzoyl Peroxide Drug Combination; Salicylic Acid

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Benzoyl Peroxide; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Adapalene; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Salicylates; Hydroxybenzoates; Hydroxy Acids; Phenols

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 100 subjects per arm

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 6, 2019
• Study Start: February 18, 2019
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

FR (1)